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How your business is affected by Novel Food regulations & our solutions

Working in the world of CBD in the European Union, you may often hear the term ‘novel food’ being used. Or perhaps you’ve never heard of this term, in which case reading this guide and article is essential. You may have wondered how CBD is classified, of course we know it’s a great plant-based supplement, but in terms of bureaucracy and paperwork – how is it officially referred to? It’s not a medical-grade drug, it’s not food or drink, and it’s not a chemical. In the EU there is a category known as ‘Novel Food’ and this is where CBD falls. We’re going to take a look into what it means to have novel food status, how to acquire it, and how this affects the production and sales of CBD for manufacturers and partners.

What is ‘Novel Food’?

The term Novel Food is classified by the European Commission as a way of defining food “that has not been consumed to a significant degree by humans in the EU before 15 May 1997,” which is when the first regulation on novel food came into action. This could be a newly developed food product, food produced using innovative technology, or even a food that is traditionally eaten in other parts of the world but not to a significant extent in the European Union. According to the Novel Food Catalogue (which lists products that have been classified as novel foods), a novel food can be of plant, animal, or another origin – essentially it could be anything consumable!

In January 2019, the European Commission officially listed CBD extracts and isolates under the Novel Foods act.

While the Novel Food Catalogue itself does not have explicit legal powers or status, it is used by the European Commission to inform decisions about new novel foods and the legislation on novel foods on the market. To put this into the context of CBD, CBD extract and isolate products have been legally classified as novel foods. This classification is an overarching umbrella for CBD in the European Union, it is then the individual decision of the member countries to legislate and regulate CBD within the realm of novel food. If you plan on doing business with other countries in the EU, be sure to check whether they have their own rules in terms of novel food legislation.

The UK’s position on CBD as a novel food

Obviously, everything right now that concerns the UK, the EU, and any kind of shared legislation – is causing a bit of a paperwork headache. Although the UK has officially left the EU, and we are currently in the transition period, the European Commission’s ruling on novel food status for CBD products will stand in place. However, this does not mean that businesses will continue as usual without any changes, all manufacturers and producers of CBD products are required to complete a Novel Foods application by the end of this month, 31 March.

a Novel Foods application
All manufacturers and producers of CBD products are required to complete a Novel Foods application by the end of this month, 31 March.

Applications for novel food status are not granted one per company or manufacturer, but rather each product. For example, if a company was selling CBD oil, CBD capsules, and CBD gummies – they would be required to complete three separate applications. Meanwhile, if there were four different flavours of gummy, this would only require one certificate/one application as they are manufactured in the same way.

Without novel foods approval, companies risk having their products removed from shelves in both UK and EU markets.

What’s Reakiro’s position when it comes to novel food status?

In order to help our wholesale, private label, and white label partners to the best of our ability, Reakiro has joined the European Industrial Hemp Association’s (EIHA) Novel Food Consortium application. If you recall, previously we mentioned that a certificate was needed per product, but then that certificate would apply for all products manufactured in the same way.

The EIHA has formed a separate company – GmbH – which is responsible for managing members’ novel food applications and authorisation processes. This consortium is effective in ensuring that similar products on the market can benefit from the same application, therefore minimising the time and paperwork that individual companies have to spend to get the right certification.

Under the EIHA’s consortium system, the association will submit novel food applications for the following four categories of hemp extract:
  1. Isolate – pure cannabidiol (CBD,) with all other cannabinoids, terpenes, and flavinoids removed, in hemp seed oil
  2. Gold – extract/distillate, honey-coloured, partial or complete decarboxylated, from Cannabis Sativa L Extract, in hemp seed oil
  3. Regular – Cannabis Sativa L extract, almost completely decarboxylated, in hemp seed oil
  4. Raw – Cannabis Sativa L extract, not thermally treated (non-decarboxylated), in hemp seed oil

CBD content in its final formulation can be up to 10% while the THC (tetrahydrocannabinol) must read below 0.2%

The EIHA have stated that in order to cover their members across the whole European market, including the UK, they “will submit two NF applications: one to the UK Food Safety Authority (FSA) for the British market, and the other to EFSA for the EU market.”

How does this help white label, private label, and wholesale Reakiro clients?

The EIHA will be issuing sublicenses to EIHA members and their partners in the consortium, and these sublicenses must be purchased in the next few weeks. There will be a more expensive licensing system for non-EIHA members.

After the consortium of EIHA members has been granted authorisation, the sublicenses which have been previously acquired can be activated. The sublicence acquirer (the CBD producer who is both an EIHA member and consortium partner) must handle these sublicenses. 

Here’s what you can do to get a sublicense from Reakiro:
  1. Define your category of sublicensee fees based on your CBD related turnover.
  2. Get documents that confirm CBD related turnover for the last three years, consolidated and average (e. g. 1 + 2 + 3 = 6 / 3 = 2), confirmed by your tax consultant (e. g. pages of balance stamped and signed by a tax consultant) OR if your company is newly registered – last consolidated balance AND expected turnover.
  3. Fill out the details of the sub-license agreement.
  4. Print and sign it and send a scanned copy together with turnover information to our legal counsel
  5. After confirmation send physical copies to our lawyer’s office in Poland: Radca Prawny Robert Wilewski, Kancelaria Radcy Prawnego, ul. Okulickiego 20, 35-206 Rzeszow For attention of: Tomasz Manderla +48 606 632 139.
  6. Pay the first instalment of sub-license fees to our bank account.

Applications for novel food licenses can take a significant amount of time to process and ultimately be approved, and this long time frame also applies to sublicenses. It’s vital that you speak to your supplier as soon as possible about your novel food status. Without the correct licensing and certification there is a sizeable risk that your CBD products could be removed from shelves in the UK and across the European Union.

The team at Reakiro are specialised in the area of novel food licences and certifications for white label, private label, and wholesale partners. Please do not hesitate to get in touch today so that we can discuss the next steps.

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